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NBI-98854 once daily · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| NBI-98854 followed by NBI-98854 with ketoconazole | EXPERIMENTAL | 50 mg NBI-98854 on Study Days 1 and 6 and 200 mg ketoconazole twice daily on Study Days 5 through 9. |
| Name | Type | Description |
|---|---|---|
| NBI-98854 50 mg capsule once daily | DRUG | - |
| Ketoconazole 400 mg (200 mg twice daily) | DRUG | - |
Inclusion Criteria: * Healthy male or female volunteer, 18 to 40 years of age. * Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study. * Female subjects must not be pregnant, given birth within 1 year of study start, or breastfeedi...
NBI-98854 once daily is an investigational small molecule developed by Neurocrine Biosciences, Inc. (ticker NBIX). It has been studied in a Phase 1 clinical trial in healthy adult subjects. The once daily designation refers to a dosing schedule of the compound.
NBI-98854 once daily is being developed by Neurocrine Biosciences, Inc., which trades on the Nasdaq under the ticker NBIX. The company sponsored the Phase 1 pharmacokinetic study of the compound conducted in the United States.
NBI-98854 once daily is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The completed study enrolled 24 healthy adult subjects and was an uncontrolled, non-randomized, non-double-blind pharmacokinetic study.
NBI-98854 once daily has been evaluated in one completed Phase 1 trial, NCT01910480, titled Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects. The trial enrolled 24 healthy volunteers in the United States and is no longer active.